FDA launches AI action plan to harness ‘enormous potential’ in medical devices
A new FDA action plan regarding AI involves further development of proposed regulatory frameworks and fostering a patient-centred…
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13 Jan 21
A new FDA action plan regarding AI involves further development of proposed regulatory frameworks and fostering a patient-centred…
In 2022, the long-standing IVDD will be replaced by the IVDR, ushering in a new era regarding how…
The UK recently adopted the GMDN classification system as part of its new medical device database, which came…
The FDA has stated that, while face masks may need to be worn during MRI scans due to…
12 Nov 20
An evolving cyber threat landscape and complex privacy laws create challenges for medical device companies looking to add…
Dr Stephen Hahn has emphasised the need for sponsors and researchers to ensure diversity, and representation of all…
30 Oct 20
The document laying out its new principles involves an acceptance that "deep rooted" systems of racism and inequity…
Democratic candidate Joe Biden will attempt to boost domestic manufacturing and make US supply chains 'more resilient' in…
The MHRA is joining the ACSS Consortium, and will begin working with regulators from Australia, Canada, Singapore and…
25 Sep 20
The new centre will advance the mobile health devices, Software as a Medical Device (SaMD), wearables medical devices,…